AU703909B3 - A form and system for placing an order for laboratory testing - Google Patents

Description

This invention relates to a system and order form for placing an order for tests on samples in a laboratory, and to a sample collection package using the form for the order of tests.

Such tests may be related to the testing of samples taken from patients for medical diagnostic purposes.

Diagnosis of medical conditions is heavily reliant not only on observation by a physician, but also on diagnostic testing of samples taken from a patient. Generally most testing on these samples is conducted by a pathology laboratory which is set up to conduct various diagnostic tests. This is the case whether the physician is working in a modern hospital or as a sole practitioner.

Generally a practitioner will send samples to one or more pathology laboratory services, and will have at hand forms, sample containers, and a plastic bag or similar sample container holder supplied by a particular pathology laboratory. The samples are taken from the patient, and filled into one or more of the sample containers, details of the patient and tests ordered are entered onto the form, and the name of the patient are written onto each of the sample containers. The completed form and the sample containers are then placed into the sample container holder, typically a purpose made plastics bag, which together with similarly packaged samples from other patients are delivered to the pathology 20 laboratory concerned.

On receipt of the samples of a patient, the pathology laboratory, typically enters details of Q the patient concerned into their database, an adhesive label with a machine readable identity code will be assigned to all samples of an order for tests. The samples are then taken 25 together with other like samples from other patients to be tested as ordered.

Each pathology laboratory handles a very large number of samples, thus for example a S, modest sized pathology laboratory will handle in the order of some millions of samples per annum. There is accordingly a need to handle each of the samples in a time efficient manner whilst still having the overriding requirement of absolute accuracy.

Similarly the physician has time pressures to ensure that the majority of patient contact time is spent with the patient rather than filling in the various formns that are required, and there is a tendency to regard fon filling as an interference with the normal role of a physician.

The filling in of forms is thus sometimes hastily peformned.

A difficulty that arises is that often there is a tendency tfor the patient informnation to be entered on the order form, however, writing on the containers to be labelled is badly done, and can be illegible, or not done at all. This tendency is compounded as a result of difficulties of writing on the curved surface presented on the container. That possibly may not be a problem where the forms and the samples arrive together in the same sample container holder, because the reception of the pathology laboratory can appropriately label such containers. At times the sample container holders are not properly closed, and samples containers are separated from the necessary information.

Such misplaced samples will require the pathology laboratory at very least to expend some time to find matching samples. At times new samples are required which places the patient at inconvenience requiring another visit to the physician or at other times when the samples are difficult to takes, such as cerebro-spinal fluid this may not be possible or entails considerable risks. At other times samples are mixed, so that the sample from a given patient is tested with the result assigned to a different patient, which can result in a misdiagnosis It is an object of the present invention to provide a means for sample identification and ordering of tests on those samples that obviates or minimises any one of the above problems or at least provides the public with a useful choice.

20 In a broad form but not necessarily the broadest or only form the invention could be said to reside in an order form to place an order for tests on samples needing testing in a laboratory, said order form including a details receiving area for receiving information necessary for the testing, a fixed machine readable indicium being fixed in relation to the order form and a removable machine readable indicium fixed in relation to a peelable label, said .peelable label peelable from the order form for adherence to a sample container, so that the removable machine readable indicia can be machine read when so adhered, said fixed machine readable indicia and the removable machine readable indicia capable of being cross referenced on a computer means identifying said indicia so that they are •"recognised as being connected to the same order for tests.

In one form fixed machine readable indicium and the removable machine readable indicium are identical.

Preferably there are provided a plurality of removable machine readable indicia all separately removable from the order form with a respective peelable label, and in one aspect of this preferred form the plurality of removable machine readable indicia and the Jr ac;"r- fixed machine indicia are identical. In one form the fixed machine readable indicium and the plurality of removable machine readable indicia have an identical commonality but have a difference to differentiate between each of them.

In that way it would be possible to identify for example different samples taken from the same patient, so that the labels could separately identify the sample tube in the event that the sample was mishandled, resulting perhaps in contamination, or if different types of samples were loaded into the separate tubes perhaps taken at different times.

In a preferred formnn it is additionally desirable to have a fixed visual indicium provided in association with the fixed machine readable indicium, and a removable visual indicium fixed in relation to the peelable label. The visual indicia may take the form of an alphanumeric string such as a nine digit number. These visual indicia are human readable and can be used to check the identity of the order form and/or the samples visually where necessary, for example when it becomes necessary to conduct a manual follow-up.

Preferably the order form comprises two sheets, a top sheet attached to a bottom sheet, the top sheet including the details receiving area and the bottom sheet underlapping the details receiving sheet there being provided duplication means so that pressure of a writing o. 20 implement makes a copy of the details enscribed on the top sheet to the bottom sheet, the fixed machine readable indicium and fixed visual indicium appearing both on the top and .o bottom sheet, and the top sheet being frangible from the bottom sheet. In this preferred ~embodiment the physician keeps a copy of the details and request for his records without •the need for photocopying and it also includes the visual and machine readable indicia identifying the specific order for tests. In the above form the peelable label may be attached to the top or bottom sheet and positioned so as not to interfere with the pressure of a writing implement making a copy of the details enscribed on the top sheet. It will also be understood that whilst two sheets are referred to, so as to make a duplicate copy, a third or more sheets may be provided for triplicate or more copies, if required.

Generally it will be desired to provide the peelable labels on the top sheet, however for the *form to be effective the peelable labels are provided on a backing sheet with properties that *prevent irreversible sticking of label adhesive thereto, so that the labels can readily be removed. Such backing sheet, because of its low adhesive properties is very difficult to receive writing or printing on. Additionally it is somewhat thicker than is desirable to allow a good copy of the enscribed information to be transcribed therethrough, and therefore it is desirable that the backing sheet at least does not underlay the details receiving -area of the top sheet of the order form.

1/ A commonly used machine readable indicia are bar codes, where a plurality of stripes and gaps encode unique numbers. Scanners for reading such bar codes are well known in the art, as is the software for interpreting and managing the results of scanning bar codes.

It will be understood that this invention is particularly useful in the medical field with patient samples for pathology testing. It will be understood, however, that the invention may also be useful in connection with other areas such as in the processing of other samples requiring laboratory testing, such as water quality testing service where water samples may be tested, or chemical analyses on various samples from perhaps mining.

In an alternative form the invention could be said to reside in a sample identification and S. testing order system for use by a testing laboratory including a plurality of order forms as defined above each having a unique fixed machine readable indicium and preferably a t o. 15 unique fixed visual indicium, so that each order formn uniquely identifies an order for tests to be conducted, and each corresponding label identifies a sample corresponding to the order form.

Alternatively the invention could reside in a package for sample collection comprising a sample container for receiving a sample from a patient, an order form and a sample 0.container holder into which the sample holder and preferable the completed order form can to too be placed, said order form being any one of the order forms defined or described in this specification.

ooo..i BRIEF DESCRIPTION OF THE DRAWING For a better understanding, the invention will now be described with reference to a preferred illustrated embodiment wherein, Figure 1 is a plan view of a top sheet of a form in accordance with the present invention.

The illustrated embodiment takes the form of a duplicate sheet, a top sheet of which is shown.

The illustrated order form includes a details receiving area which takes up the majority of the top sheet of the order form. A fixed machine readable indicium takes the form of a bar code. This fixed indicium is printed onto the top sheet and cannot be removed therefrom. Three removable machine readable indicia 4, 5) are printed onto three labels 7, The labels form part of the top sheet which labels have adhesive on their lower surface, which lower surface is covered by a backing sheet made of a paper of the type to which the adhesive does not adhere well. The extend of the backing sheet is shown by broken lines As can be seen this backing sheet underlies portions of the top sheet not requiring duplication to the bottom sheet. The top sheet is cut around each of the labels, so that they can be removed by lifting a free tab 10, 11) to peel the respective label off.

It can be seen that in addition to the machine readable indicia, each of the labels and the fixed indicia also have a visual indicium The visual indicium is an alphanumeric one being a nine digit number (in this case being, 11 2075311), which then serves as a visual ."indicium of the specific order for tests that is to be made. It may be desired that a further .digit be added to differentiate between the samples and thus the digits a, b, and c may be used after the number for the different samples respectively.

99* A bottom sheet which is not shown is adhered to a common strip (12) of the order form and can be torn therefrom by tearing through the perforated cut A duplication system "is used between the top sheet and bottom sheet, such as are known in the art, perhaps in 9*9 ~the form of a carbonless copying system. Thus where a writing implement such as a pen is used to enscribe information onto the top sheet, the pressure of the pen on the top sheet transcribes the same information onto the bottom sheet. It will be understood that it is 9 "desirable that the layout of the bottom sheet is substantially identical to the top sheet so that the transcribed information is intelligible to the reader of the bottom sheet on its own.

*99*99 o 25 The order form is part of a system of ordering that is administered by a particular pathology service or division of a pathology service. The particular pathology laboratory will provide a package for the convenience of the physician or other medical practitioner.

A pad of forms could be provided or separate packages of forms together with a set of tubes which in the illustrated embodiment will comprise three tubes, and additionally, a suitably sealable bag. Each of the forms will have a unique set of bar codes representing the fixed and visual indicia which might be considered to represent an order number. The dimensions of the labels are such that they comfortably fit longitudinally on the sample tubes.

The details of the patient and tests required are filled in into the details receiving area of the top sheet, the requisite samples are taken in the approved manner by the physician and placed into one, two or three sample containers which will usually take the form of capped plastic tubes. Labels will be removed from the form, and adhered to the tubes, along their longitudinal axis. The tubes will be placed into the sealable bag, together with the top sheet of the order form ready for return to the pathology service provider.

It can be seen then that whilst it is important that the details of the specific order for tests is properly completed, the bar codes are the same and therefore should the "surname" of the patient not be filled in it matters very little insofar that those details can be ascertained from the details receiving area of the order form.

When a given order form and accompanying samples enter the reception of the pathology service, details from the order form are entered into the database of the pathology service, for use in the diagnostic test reading apparatuses to the extent that they are automated.

S C In the event that the tubes are misplaced, or order forms are separated from the tubes, provided that the tubes are present the physician concerned can be contacted because a .15 record is kept of the physician that is sent a certain block of order numbers and by cross referencing the visual indicium on the label of the tube, test order details can readily be determined. A copy of the details can be sent, for example by facsimile transmission, SC from the physician to the pathology laboratory if necessary.

The pathology service provider also does not need to undergo the cost of having labels separately applied at reception.

oo S.f 8 THE CLAIMS DEFINING THE INVENTION ARE AS FOLLOWS:- 1. A pathology test order form to place an order for tests on samples needing testing in a laboratory, said order form including; a bottom sheet frangibly attached to a top sheet; a details receiving area upon the top sheet for receiving the information necessary for the testing and adapted such that a person ordering tests need only once enter necessary information for the tests; the bottom sheet underlapping the details receiving sheet and there being provided duplication means so that pressure of a writing implement makes a copy of the details enscribed on the top sheet to the bottom sheet; a fixed machine readable indicium being a bar code and fixed in relation to the order form; a removable machine readable indicium being a bar code and fixed in relation to a peelable label, said peelable label peelable from the order form for adherence to a sample container, so that the removable machine readable indicium can be machine read when so adhered; and, said fixed machine readable indicium and the removable machine readable indicium 20 capable of being cross referenced on a computer means identifying said indicia so that they are recognised as being connected to the same order for tests.

2. An order form as in claim 1 having a human readable fixed visual indicium provided in association with the fixed machine readable indicium, and a human readable 25 removable visual indicium fixed in relation to the peelable label.

3. An order form as in either claim 1 or 2 wherein the fixed machine readable indicium and any fixed visual indicium appear both on the top sheet and the bottom sheet, and the bottom sheet being substantially identical to the top sheet.

~30 4 Dated this 14th day of October 1998 MEDVET SCIENCE PTY LTD By their Patent Attorneys, A. P. T. Patent and Trade Mark Attorneys 0 I\